HAWAIIAN NATURAL ZINC SUNSCREEN SPF 50- zinc oxide lotion

Hawaiian Natural Zinc Sunscreen SPF 50 by

Drug Labeling and Warnings

Hawaiian Natural Zinc Sunscreen SPF 50 by is a Otc medication manufactured, distributed, or labeled by Kokua Sun Care, Vege Labs LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient Purpose

Zinc Oxide 25% Sunscreen

PURPOSE

Uses

• Helps prevent sunburn
• If used as directed with other sun protection measures (see Directions), Decreases the risk of skin cancer and early skin aging caused by the sun.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs

WARNINGS

Warnings:

• For external use only
• Do not use or broken skin
• When using this product keep out of eyes

DOSAGE & ADMINISTRATION

Directions

• Apply generously 15 minutes before sun exposure
• Reapply:
• After 80 minutes if swimming or sweating
• Immediately after towel drying
• At least every 2 hours
• Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
• Limit time in the sun, especially from 10 am-2pm.
• Wear long-sleeve shirts, pants, hats, and sunglasses.
• Children under 6 months: ask a doctor.

INACTIVE INGREDIENT

Inactive Ingredients

Water (Aqua), Aloe Barbadensis Leaf Juice, Caprylyl Caprylate/Caprate, Macadamia Ternifolia Seed (Macadamia Nut) Oil, Aleurites Moluccana Seed (Kukui nut) oil, Polyglyceryl-2 Oleate, Polyhydroxystearic Acid, Glycerin, Cocos Nucifera (Coconut) Oil, Cetyl Dimethicone, Magnesium Sulfate, Hydrogenated Methyl Abietate, Galactoarabinan, Propanediol, Polyglyceryl-2 Stearate, KonaRed Hawaiian Coffee Fruit Extract, Morinda Citrifolia Fruit Juice (Noni), Arthrospira Platensis (Hawaiian Spirulina), Oryza Sativa (Rice) Bran Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Helianthus Annuus (Sunflower) Seed Extract, Caprylic/Capric Triglyceride, Prunus Armeniaca (Apricot) Fruit Extract, Musa Sapientum (Banana) Fruit Extract, Santalum Album (Sandalwood) Extract, Butter Extract, Coffea Arabica (Coffee) Leaf/seed Extract, Pyrus Malus (Apple) Fruit Extract, Cocos Nucifera (Coconut) Fruit Extract, Helianthus Annuus (Sunflower) Seed Oil, Tocopherol, Plumeria Alba Flower Extract, Kaolin, Hydrogenated Vegetable Oil, 1,2-Hexanediol, Caprylhydroxamic Acid

PRINCIPAL DISPLAY PANEL

Hawaiian Natural Zinc Sunscreen

Broad Spectrum SPF 50

Water Resistant 80 minutes

89 mL / 3 FL OZ

INGREDIENTS AND APPEARANCE

HAWAIIAN NATURAL ZINC SUNSCREEN SPF 50 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72096-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	25 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
KUKUI NUT OIL (UNII: TP11QR7B8R)
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)
MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I)
ARABICA COFFEE BEAN (UNII: 3SW678MX72)
COCONUT (UNII: 3RT3536DHY)
SUNFLOWER OIL (UNII: 3W1JG795YI)
PLUMERIA ALBA FLOWER (UNII: LGC8P2PC4H)
CAPRYLYL CAPRYLATE/CAPRATE (UNII: 22MCG4RSMR)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
APRICOT (UNII: 269CJD5GZ9)
VANILLA (UNII: Q74T35078H)
MUSKMELON (UNII: ZV095H5633)
KAOLIN (UNII: 24H4NWX5CO)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
MACADAMIA OIL (UNII: 515610SU8C)
COCONUT OIL (UNII: Q9L0O73W7L)
HYDROGENATED METHYL ABIETATE (UNII: A23O709X8O)
GALACTOARABINAN (UNII: SL4SX1O487)
PROPANEDIOL (UNII: 5965N8W85T)
POLYGLYCERYL-2 STEARATE (UNII: 253MC0P0YV)
COFFEA ARABICA FRUIT (UNII: HOX6BEK27Q)
NONI FRUIT JUICE (UNII: 6ULF85Z07J)
ARTHROSPIRA PLATENSIS (UNII: 9L3TIH1UUE)
RICE BRAN (UNII: R60QEP13IC)
ROSEMARY (UNII: IJ67X351P9)
CRANBERRY (UNII: 0MVO31Q3QS)
BANANA (UNII: 4AJZ4765R9)
APPLE (UNII: B423VGH5S9)
TOCOPHEROL (UNII: R0ZB2556P8)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SANDALWOOD (UNII: 3641YW25N2)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72096-101-01	89 g in 1 BOX; Type 0: Not a Combination Product	02/10/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	02/10/2018

Labeler - Kokua Sun Care (081062410)

Establishment
Name	Address	ID/FEI	Business Operations
Verde Cosmetic Labs, LLC		080656433	manufacture(72096-101)